Asept Surgical Face Mask
FDA 510(k) K201137 · Pfm Medical, Inc.
510(k) numberK201137
Submission
- Device name
- Asept Surgical Face Mask
- Applicant
- Pfm Medical, Inc.
Carlsbad, CA, US - Received
- April 28, 2020
- Decision date
- August 19, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FXX – Mask, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FXX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251967 | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*…FXX · Traditional | O&M Halyard, Inc. | 03/18/2026SE |
| K252534 | Surgical Face Mask (Ear mount)FXX · Traditional | Zhejiang Hangkang Medical Equipment Co., Ltd. | 03/03/2026SE |
| K253398 | Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)FXX · Special | Efofex, Inc. | 02/19/2026SE |
| K252830 | Disposable Surgical Face Mask (3P00B, C2900)FXX · Traditional | Beatles Medical Supplies (Xiantao) Co., Ltd. | 01/12/2026SE |
| K252650 | Disposable Medical Face MaskFXX · Traditional | Makrite Industries, Inc. | 01/05/2026SE |
| K243342 | KP Protective Face MaskFXX · Traditional | Kp Trading Co., Ltd. | 12/22/2025SE |
| K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsFXX · Traditional | O&M Halyard, Inc. | 12/11/2025SE |
| K252964 | PRIMED Surgical and Procedure MasksFXX · Traditional | Primed Medical Products, Inc. | 11/04/2025SE |
| K251902 | Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield…FXX · Traditional | Vitacore Industries, Inc. | 09/17/2025SE |
| K250082 | Procedure mask/Surgical mask/Face maskFXX · Traditional | Winner Medical Co., Ltd. | 06/18/2025SE |
More from Winner Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K242763 | JetCan® Pro Safety Huber NeedleFPA · Traditional | 05/02/2025SE |
| K241278 | ASEPT® Glide Peritoneal Drainage SystemPNG · Traditional | 01/14/2025SE |
| K221779 | ASEPT Peritoneal Drainage SystemPNG · Traditional | 05/02/2023SESK |
| K213666 | NuCath Wedge Pressure CatheterDQO · Traditional | 10/06/2022SE |
| K192802 | primeMidline CathetersPND · Special | 10/28/2019SE |
| K173114 | primeMidline CathetersPND · Traditional | 03/07/2018SE |
| K140137 | Safety Biopsy Needle SystemFCG · Traditional | 03/25/2014SE |
| K122402 | LPP (Low Profile Port)LJT · Traditional | 07/16/2013SE |
| K113354 | Veta Peritoneal Dialysis CatheterFJS · Traditional | 03/13/2012SESK |
| K110914 | Triple Lumen PFM PiccLJS · Traditional | 09/21/2011SE |
Questions and answers
When was Asept Surgical Face Mask cleared by the FDA?
Asept Surgical Face Mask (K201137) received a 510(k) decision of Substantially Equivalent on August 19, 2020, 113 days after the submission was received.
What is the product code of K201137?
The FDA product code is FXX – Mask, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4040.